OBJECTIVES: To compare real-world vs. labeled anti-tumor necrosis factor dosing in adults with CD. METHODS:  A retrospective claims analysis was conducted for CD patients aged ≥18 years using Wolters Kluwer Health’s Source Lx Longitudinal patient database. Newly initiated adalimumab (ADA) or infliximab (IFX) patients, determined by a 90-day absence of claims for either agent prior to the index date, with continuous enrollment and therapeutic persistence for the study duration, were analyzed. Labeled dose was calculated monthly as the cumulative sum of 40 mg syringes (ADA) or 100 mg vials (IFX) required from the first day of the index month through December 31, 2007, inclusive of induction and maintenance dosing. The IFX labeled dose assumed 4-8 vials per infusion, representing the labeled dose range (5 mg/kg - 10 mg/kg) for an average patient weighing 71 kg, which was the mean weight of patients in the IFX clinical trial. Mean cumulative utilization was analyzed for each drug monthly and compared with the labeled dose. RESULTS: There were 1299 patients with ADA (average age 41.6; 61% female) and 2118 patients with IFX (average age 42.9; 57% female). For ADA, 48.6% patients were at or below the labeled dose, while 51.4% were above the labeled dose. The average difference between mean prescribed dose and labeled dose for ADA was +5.51 syringes. For IFX, 57.7% patients were below the lowest labeled dose of 5mg/kg, 32.9% were within the 5 mg/kg to 10 mg/kg range, while only 9.4% were above the highest labeled dose of 10 mg/kg. The average difference between mean prescribed dose and lowest labeled dose (5 mg/kg) was -2.10 vials. CONCLUSIONS: In CD, most (51.4%) ADA patients were above the labeled dose, while few (9.4%) IFX patients were above the labeled dose. Payers should analyze their own data to determine if these same trends are seen and, determine the impact of these dosing patterns to the plan.